NCT02195219

Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment. For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.

Detailed description

Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries. There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6. For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them. During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient. The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.

Conditions

• Acromioclavicular Joint Dislocation

Interventions

Type	Name	Description
PROCEDURE	open reduction internal fixation	MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.
OTHER	sling rest and early functional recovery	Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-07-21
• Last updated: 2018-03-16

Locations

1 site across 1 country: Spain